RAINDROP INLAY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-13 for RAINDROP INLAY manufactured by Revision Optics / Rvo 2.0 Inc..

MAUDE Entry Details

Report NumberMW5089010
MDR Report Key8893333
Date Received2019-08-13
Date of Report2019-08-12
Date of Event2017-05-17
Date Added to Maude2019-08-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameRAINDROP INLAY
Generic NameIMPLANT, CORNEAL, REFRACTIVE
Product CodeLQE
Date Received2019-08-13
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerREVISION OPTICS / RVO 2.0 INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-08-13

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